Urushiol induced contact dermatitis solution

ABSTRACT

A solution for urushiol induced contact dermatitis is provided for in a topical solution. According to the invention, a method is provided for applying a composition of substances to the affected area, working the composition into the affected area, and removing the composition from the affected area. The composition comprises at least one ethoxylate in combination with a supporting agent. It is believed that this combination binds to the available urushiol receptors rendering it inactive. The affinity of the receptors for the ethoxylates also appears to cause a release of the urushiol from its epidermal bonds for bonding to the composition. An inert scrubbing agent, such as polyethylene beads, can also be included to assist in the release of the urushiol. Acetylated lanolin alcohol, EDTA, a foam stabilizer, and water can also be added to the composition without effecting performance.

I. RELATED APPLICATION

[0001] This application is a Continuing Prosecution Application (CIPtype) of parent application Ser. No. 09/347,714.

II. FIELD OF THE INVENTION

[0002] The present invention relates to solutions for allergicdermatitis and more particularly to a solution for Toxicodendrondermatitis, which results from contact with the Rhus oleoresin,urushiol.

II. BACKGROUND OF THE INVENTION AND PRIOR ART

[0003] Urushiol is the toxin responsible for the dermatitis caused bycontact with the sap of commonly encountered noxious plants such aspoison ivy (T. rydbergii (Northern and Western poison ivy) and T.radicans ssp. radicans (Eastern poison ivy)), poison oak (T. toxicarium(Eastern poison oak) and T. diversilobum (Western poison oak)), poisonsumac (T. vernix), and related plants found throughout the world. Theseplants are in the Anacardiaceae group, which also includes, amongothers, the lacquer tree of Asia, the mango tree, cashew shell oil, andcertain nutshells, such as the walnut. (Throughout this document,reference to poison ivy is meant to also include other urushiolcontaining plants.)

[0004] When located inside an unruptured plant, urushiol is a light,colorless oil. When exposed to oxygen, urushiol easily oxidizes and,after polymerizing, turns a blackish color. The slightest contact oreven breeze easily damages the leaves. Therefore, it is rare to find aplant that does not have at least some ruptured leaves. Most peoplebelieve that poison ivy infection can only result from contact with theleaves of the plant. This is not true. Urushiol is found not only in theleaves but also vines and stem and root systems. The urushiol in theroot system and vines is pure and is ten to 100 times more potent thanthat found in leaves. Accordingly, contact with cut or broken vines, orroot systems will almost always result in a reaction.

[0005] Experts estimate there are up to 55 million cases ofurushiol-induced contact dermatitis annually in the United States.Roughly 85 percent of all people will develop an allergic reaction whenadequately exposed to poison ivy. People who reach adulthood withoutbecoming sensitive have only a 50 percent chance of developing anallergy to poison ivy. Sensitivity to poison ivy tends to decline after72 years of age as the immune system is less reactive. Children underthe age of 1 year do not typically react to urushiol as their immunesystems are not yet fully developed.

[0006] The American Academy of Dermatology estimates that there are upto 50 million cases of urushiol induced contact dermatitis annually inthe United States alone. No one is sure of the number of world wideannual exposures but some experts estimate that the number could bedouble that of the United States. Accordingly, urushiol induced contactdermatitis is a world wide problem.

[0007] Chemically, urushiols are mixtures of catechols with long,hydrophobic, carbon (alkyl) side chains at the three position of thecatechol ring. For example, poison ivy contains predominantly3-n-pentadececylcatechols (C-15) and poison oak contains predominantly3-n-heptaecylcatechols (C-17).

[0008] Current theory suggests that the reaction to urushiol is adelayed cell-mediated immune response in which, upon first exposure,urushiol penetrates the stratified squamous epithelial cells and bindsto the Langerhan cells, which, in turn, sensitize effector T-cells inthe lymph system. Subsequent exposures to urushiol result in the releaseof cytokines and reaction by macrophages and cytotoxic T-Cells. Theresult of lytic enzyme and perforin release is destruction of themembrane-bound urushiol and surrounding skin cells, which presents asthe commonly seen clinical picture.

[0009] Once urushiol touches the skin, it begins to penetrate inminutes. It is completely bound to the skin after eight hours (two tosix hours according to some experts). The rash generally develops withintwo days. Redness and swelling occur, often followed by blisters andsevere itching. In a few days, the blisters may become crusted and beginto scale. The rash generally peaks after five days, and starts todecline after about a week or 10 days. The rash takes two or more weeksto heal. In a severe case or in a systemic reaction, individuals willmany times present with black spots in areas of heavy urushiolconcentration. The black spots are polymerized urushiol in a pure formand need to be removed immediately. This “Black Spot” test (attributedto Guin) is good indicator of a severe reaction, localized or systemic,or is often seen in cases of poison oak (typically a more tenaciousreaction than poison ivy).

[0010] The rash can affect almost any part of the body, especially wherethe skin is thin, such as on the face. A rash develops rarely on thesoles of feet and palms of hands, where the skin is thicker. The rashdoes not spread, although it may seem to do so when it breaks out in newareas. This may happen because urushiol absorbs more slowly into skinthat is thicker, such as on forearms, legs and the body's trunk.Urushiol can be transferred by fingernails or animal fur and can remainon clothing, shoes, and tools for up to five years in moist climates andnine years in dry climates. Scratching the rash does not spread theurushiol to other parts of the body, but it can prolong the discomfortand cause a secondary infection.

[0011] Solution has historically consisted of attempting to remove theoil as quickly after exposure as possible: applying rubbing alcohol,washing affected areas with water, and showering with soap and water. Inmany instances, however, people either fail to fully remove the toxinbefore it has bound to the skin or don't realize they have been exposeduntil after the rash appears.

[0012] Over-the-counter solutions are legion; a partial list of the mostpopular includes hydrocortisone creams and ointments, diphenhydraminegels, calamine lotion, and the proprietary product, Ivy Dry®*.Hydrocortisone, diphenhydramine, and calamine lotion are palliatives andoffer only temporary relief from the itching associated withToxicodendron contact dermatitis. They do nothing to remove urushiolfrom the skin. Likewise, Ivy Dry® provides essentially a cooling effectthat is only temporary. It may, if used before the urushiol binds to theskin, remove some of the urushiol.

[0013] Attempts have been made to find both prophylactic solutions aswell as post-exposure solutions. To date, no vaccine has been developedand the prior art solutions are not without shortcomings. One solutionexample is seen in U.S. Pat. No. 5,686,074 to Stewart which teaches andclaims a solution for poison ivy which includes a composition includinglinseed oil, an astringent, a starch, an essential oil and a citrus oil.One shortcoming of this patent is that linseed oil can cause irritationitself. A second shortcoming of this patent is that it requires that thecomposition be applied to the affected areas up to twice a day until therash is gone. The composition provides what appears to be only verytemporary palliative relief of poison ivy symptoms and does not appearto alter the course of the malady.

[0014] Other proposed solutions are seen in U.S. Pat. Nos. 5,620,527,5,011,689 4,499,086, 4,259,318, 4,002,737, 3,862,331, 3,875,301, and3,922,342.

[0015] Yet other prior art attempts have focused on prophylactics forpreventing the dermatitis. One example is seen is U.S. Pat. No.4,663,151 to Waali that discloses and claims a prophylactic solutionbased upon Aluminum Chlorhydrate.

[0016] Of course, the most significant shortcoming associated withprophylactic solutions is that they are only effective if applied beforeexposure to the urushiol; an occurrence that rarely takes place.

[0017] Tec Laboratories, Inc. of Albany, Oreg. markets an unpatentedproduct sold under the mark Tech-Nu. This product also is not withoutshortcomings. This product was originally developed as a solution forradiation exposure. It was discovered, however, that the product alsoprovided some relief for poison ivy exposure. The main active ingredientin the Tech-Nu® product is Octylphenoxy-polyethoxyethanol. The fouroctyl groups of this chemical are too large too surround the non polarmoieties in the urushiol. Therefore, it only partially matches thepolarity of urushiol. Thus, the action of this product renders theurushiol only partially inactive. Since the urushiol remains partiallyactive and continues to cause irritation, only temporary relief isprovided and multiple applications are necessary. Also, the chemicalmakeup of the product requires that it be applied no later than eighthours after exposure to urushiol.

[0018] There is need, therefore, for a safe, effective solution fordermatitis caused by exposure to the toxin urushiol. The solution shouldprovide complete relief from the signs and symptoms associated with thedermatitis in limited solutions and be effective at any point during thedermatitis cycle.

II. OBJECTS OF THE INVENTION

[0019] It is an object of the present invention to provide a solutionfor urushiol induced allergic dermatitis (Toxicodendron dermatitis), thesolution providing almost immediate and permanent relief in usually onesolution.

[0020] It is a further object of the present invention to provide such asolution that utilizes a composition that chemically attaches toavailable urushiol receptors to block its allergic reaction propertiesand to release the urushiol so that it can be removed from the skin.

[0021] It is a yet further object of the present invention to provide asolution that is safe to use.

[0022] It is yet another object of the present invention to provide asolution for urushiol induced allergic dermatitis that is topical, canbe purchased over the counter and is economical.

IV. SUMMARY OF THE INVENTION

[0023] The above objects of the invention are provided for in a topicalsolution for use in urushiol induced contact dermatitis. According tothe invention, a composition of substances is applied to and worked intothe affected area. The solution is permitted to stay on the affectedarea a sufficient amount of time such that the solution has bonded withthe urushiol, and the solution-urushiol complex is removed from theaffected area. A secondary effect of the solution is that it interactswith the C fibers of the nervous system to provide itch relief.

[0024] The composition comprises at least one ethoxylate in combinationwith a compatible wetting agent, for non-limiting example, SodiumLauroyl Sarcosinate (or SLS). It is believed that this combinationcreates an urushiol-complimentary polar substance that binds withavailable urushiol receptors rendering it inactive. The affinity of thereceptors for the ethoxylates also appears to cause a release of theurushiol from its epidermal bonds creating a micelle with the inventivesolution. An inert scrubbing agent, such as polyethylene beads orpumice, can also be included to assist in the release of the urushiol.Acetylated lanolin alcohol, EDTA, a foam stabilizer, water and othervarious agents can also be added to the composition without effectingperformance.

V. DETAILED DESCRIPTION OF THE INVENTION

[0025] As noted above, urushiol is the toxin responsible for the contactdermatitis caused by poison ivy, poison oak, and other urushiolcontaining plants. When housed inside an unruptured plant leaf, urushiolis a light, colorless oil. The slightest contact or even breeze easilydamages the leaves. Therefore, it is rare to find a plant that does nothave at least some ruptured leaves. When exposed to oxygen, urushioleasily oxidizes and, after polymerizing, turns a blackish color.

[0026] The reaction experienced by most people is the result of exposureto the oleoresin containing the urushiol. The reaction is an allergiceczematous contact dermatitis characterized by redness, swelling,papules, vesicles, bullae, and streaking. Urushiol is the name given toa family catechols having long, hydrophobic, carbon (alkyl) side chainsat the three position of the catechol ring. The urushiol of the poisonivy plant contains predominantly 3-n-pentadececylcatechols (C-15).Poison oak is known to contain predominantly 3-n-heptaecylcatechols(C-17). Other urushiol containing plants contain catechols that haveside chains of varying lengths.

[0027] The inventor discovered that a hand scrub product manufacturedand sold by the Redman Scientific, Company of Dallas, Tex. can alleviatethe signs and symptoms of urushiol induced contact dermatitis. Theproduct has been sold for approximately twenty years, and is known to bea safe, gentle hypoallergenic product. The product has been sold as anindustrial hand cleaner and has never heretofore been known to beeffective against urushiol toxicity. It has only been promoted as a handcleaner.

[0028] Chemical analysis and research has revealed that two of thecomponent parts of the Redman product are central to its effectivenessas a solution for urushiol induced contact dermatitis: an ethoxylate andSodium Lauroyl Sarcosinate. The ethoxylate is a nonylphenol ethoxylate.The present invention's ethoxylate has the large octyl groups removed.In this way, the ethoxylate can “wrap” around the non-polar molecules ofthe urushiol. Further, the long chain moiety of the present invention'sethoxylate is only four carbons long, as opposed to, for example, thatseen in Tec-Nu®. This feature also assists the ethoxylate in bonding tothe urushiol more effectively. (It is important to note that more thanone surfactant can be used at a time. Accordingly, the ethoxylate may beused alone or in conjunction with other surfactants to create theappropriate environment.)

[0029] However, the ethoxylate itself is not capable of forming acomplete micelle with the urushiol. It was discovered that the additionof Sodium Lauroyl Sarcosinate completes a micelle and the urushiol canbe cleansed away from the skin. SLS also has a long carbon chain thatcan surround the non-polar portions of the urushiol. In addition, SLScontains a highly polar end that aids in surrounding the polar ends ofurushiol and also in the invention's reactivity with water.

[0030] Thus, the combination of the ethoxylate and SLS create a largemolecule that contains flexible non-polar groups and soluble polargroups. This permits the inventive composition to quickly andeffectively surround the urushiol and then be rinsed away with water, ahighly polar substance.

[0031] Further research by the Inventor has revealed that othersubstances (“hereinafter termed “supporting agents”) also are effectivein combination with ethoxylates to bind and neutralize urushiol. Forexample, d-limonene can be used in combination with an ethoxylate tocreate an effective urushiol binding or neutralizing agent. The chemicalresult of the ethoxylate/d-limonene combination has an affinity tourushiol that is close but not the same as SLS; thus, d-limonene can bea suitable, but somewhat less effective, substitute for SLS. Further,d-limonene is known to be a mild skin irritant and may cause undueirritation of already disrupted skin.

[0032] Other substances that form with the ethoxylate to form a moleculethat can create a micelle with the urushiol can also work as supportingagents.

[0033] Inert scrubbing agents improve the action of the inventivecomposition. The scrubbing agent assists by causing the urushiol todetach from the skin and place it in position for bonding with theactive chemical components of the inventive composition. Any inert agentwill suffice but the inventor believes that polyethylene beads workbest. Another suitable inert agent includes pumice. The scrubbing agentshould be large enough to be effective but not so large as to causeabrasions. Scrubbing agents should be in the range of 5 to 50 micronswith an average size being approximately 25 microns or 50 mesh. Whilescrubbing agents are desirable, they are not critical to the inventionuse.

[0034] To make the inventive composition, an exact ratio of ethoxylateand supporting agent is not critical. The only requirement is that theethoxylate completely reacts with the supporting agent, creating apolymer. This will vary with the ethoxylate and supporting agent used,but, in the case of SLS, a ratio of ethoxylate-to-SLS of 1.5:2 ispreferred. The amount by weight of scrubbing agent can vary according tothe grittiness desired. In the case of SLS and polyethylene beads, aformula of ethoxylate:SLS:polyethylene of 40:20:40 is preferred but thatformulas of other concentrations are useful. Thus, for productionpurposes, formulas having a supporting agent ranging from 10 to 20% byweight, ethoxylate ranging from 20 to 40% by weight, and scrubbing agentfrom 20 to 50% by weight are reasonable. But again, the formula is notrestricted to these ranges, which ranges are presented for examplepurposes only.

[0035] Also, a cutting agent that does not chemically react with thecomposition may be added but is not required. The cutting agent makesthe overall composition flow more easily, thereby enabling morepackaging options such as tubes. The cutting agent can be either anaqueous based solution or an oil based solution. The cutting agent mustbe added only in sufficient amount that it promotes flow but does noteffect the action of the composition.

[0036] Thus, a representative composition for the inventive solutionmight be polyethylene granules, sodium lauroyl sarcosinate, nonoxynol-9,C12-15 pareth-9, disodium EDTA, quaternium-15, carbomer 2%,triethanolamine, and water.

[0037] In use, the composition is applied to an affected area and workedover the area by a scrubbing motion. After sufficient time has elapsedto ensure that the affected area has been adequately exposed to thecomposition, typically thirty seconds to three minutes depending on theagents used, severity of the reaction, and the sensitivity of theindividual, the composition and bound urushiol are washed away. To havethe greatest effect, the composition can be left on the affected area,after the initial scrubbing, for a short time, thirty to sixty seconds,a second rubbing can be accomplished. The second rubbing period can beshorter than the initial period and than washed away. Experiments havedemonstrated that a majority of people needs only one solution to berelieved of itching; however, severe or systemic cases may require twoor more application approximately eight hours apart for two days to befully effective. The inventive composition works at varying rates ofeffectiveness at any time during the rash cycle.

I claim:
 1. A solution for urushiol induced contact dermatitiscomprising a supporting agent and at least one ethoxylate incombination.
 2. The solution for urushiol induced contact dermatitis ofclaim 1 wherein one of the at least one ethoxylate is a nonyl phenylethoxylate.
 3. The solution for urushiol induced contact dermatitis ofclaim 1 further wherein the supporting agent is sodium lauroylsarcosinate.
 4. The solution for urushiol induced contact dermatitis ofclaim 1 further wherein the supporting agent is d-limonene.
 5. Thesolution for urushiol induced contact dermatitis of claim 1 furtherincluding Acetylated lanolin alcohol.
 6. The solution for urushiolinduced contact dermatitis of claim 1 further including a scrubbingagent.
 7. The solution for urushiol induced contact dermatitis of claim6 wherein the scrubbing agent is polyethylene granules.
 8. The solutionfor urushiol induced contact dermatitis of claim 6 wherein the scrubbingagent is pumice.
 9. The solution for urushiol induced contact dermatitisof claim 1 further including water.
 10. The solution for urushiolinduced contact dermatitis of claim 1 further includingethylenediaminetetraacetic acid.
 11. The solution for urushiol inducedcontact dermatitis of claim 1 further including a foam-stabilizingagent.
 12. The solution for urushiol induced contact dermatitis of claim1 further including a cutting agent.
 13. The cutting agent of claim 12being selected from the group of aqueous based solutions and oil basedsolutions.
 14. A solution for urushiol induced contact dermatitiscomprising at least one ethoxylate, a supporting agent, and scrubbingmeans.
 15. The solution for urushiol induced contact dermatitis of claim14 wherein one of the at least one ethoxylate is a nonyl phenylethoxylate.
 16. The solution for urushiol induced contact dermatitis ofclaim 14 further wherein the supporting agent is sodium lauroylsarcosinate.
 17. The solution for urushiol induced contact dermatitis ofclaim 14 further wherein the supporting agent is d-limonene.
 18. Thesolution for urushiol induced contact dermatitis of claim 18 wherein thescrubbing agent is polyethylene granules.
 19. The solution for urushiolinduced contact dermatitis of claim 18 wherein the scrubbing agent ispumice.
 20. The solution for urushiol induced contact dermatitis ofclaim 14 further including water.
 21. The solution for urushiol inducedcontact dermatitis of claim 14 further including Acetylated lanolinalcohol.
 22. The solution for urushiol induced contact dermatitis ofclaim 14 further including ethylenediaminetetraacetic acid.
 23. Thesolution for urushiol induced contact dermatitis of claim 14 furtherincluding a foam-stabilizing agent.
 24. The solution for urushiolinduced contact dermatitis of claim 14 further including a cuttingagent.
 25. The cutting agent of claim 14 being selected from the groupof aqueous based solutions and oil based solutions.
 26. A method fortreating contact dermatitis comprising the steps of: preparing acomposition comprising at least one ethoxylate and a supporting agent;applying the composition to an affected area; scrubbing the compositionon the affected area; permitting the composition to remain on theaffected area a sufficient amount of time to enable the composition ofmatter to cause an effect; and, removing the composition from theaffected area.
 27. The method of claim 26 including the further step ofadding a scrubbing agent to the composition
 28. The method of claim 26wherein the scrubbing agent is polyethylene granules.
 29. The method ofclaim 26 wherein the scrubbing agent is pumice.
 30. The method of claim26 wherein preparing the composition further includes adding Acetylatedlanolin alcohol.
 31. The method of claim 26 wherein preparing thecomposition further includes adding water.
 32. The method of claim 26wherein preparing the composition further includes EDTA.
 33. The methodof claim 26 wherein preparing the composition further includes a foamstabilizer.
 34. The method of claim 26 further including the step ofadding a thinning agent to the composition.